Wound care devices, apparatus, and treatment methods

ABSTRACT

A wound care device for delivering topical oxygen therapy, negative pressure wound therapy, and a low intensity vacuum therapy for treatment of a wound. The wound care device may include an oxygen supply mea, an oxygen consuming mea, a vacuum pump and motor, a pressure sensor, and a power supply and electronic controls. A dressing may be connected to the wound care device for administering topical continuous oxygen therapy and simultaneous negative pressure wound therapy to a wound. A canister or exudate trap may be positioned between the dressing and the vacuum supply port of the vacuum pump to collect and store exudates from the wound. The canister may be combined with the dressing.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/819,640, filed Aug. 6, 2015, and issued as U.S. Pat. No. 9,770,369 onSep. 26, 2017, which application claims the benefit of U.S. ProvisionalApplication No. 62/035,233 filed on Aug. 8, 2014. The specifications ofU.S. patent application Ser. No. 14/819,640 and U.S. ProvisionalApplication No. 62/035,233 are incorporated herein by reference in theirentireties.

FIELD OF THE INVENTION

The present invention generally relates to wound care. Moreparticularly, this invention relates to a mobile device and apparatusfor the application of negative pressure wound therapy along withtransdermal oxygen delivery.

BACKGROUND

Negative Pressure Wound Therapy (NPWT) may be used to treat wounds,including acute wounds, chronic wounds, pressure ulcers, and diabeticfoot ulcers. For example, a dressing may be applied to a chronic woundto form an airtight seal, and a pump may be connected via a tube to thedressing to evacuate air from the dressing and draw drainage from thewound. NPWT may accelerate wound healing by various mechanismsincluding: removal of exudate, reduction of edema, contraction of woundedges, stimulation of angiogenesis, changes in the wound edges, andproduction of granulation tissue. Nevertheless, wound treatment withNPWT may provide limited efficacy should the healing process stall orcontraindications, such as advancing infection in the wound, develop.Although oxygen delivery therapies may be used to successfully treatwounds, including wounds that have failed NPWT, a need exists for newdevices and systems that may improve patient outcomes and expand accessto patients with limited mobility or clinical support.

SUMMARY

Hence, the present invention is directed to a wound care device andapparatus that may be used to simultaneously apply transdermalcontinuous oxygen therapy and negative pressure wound therapy to awound. The present invention also is directed to an apparatus and methodfor the intermittent application of negative pressure wound therapy andtransdermal oxygen to a wound.

In one aspect, the present invention is directed to a wound care devicethat includes a vacuum port for supplying a vacuum source to an externalelement, and an oxygen port for supplying oxygen gas to another externalelement. The device further may include an oxygen generating devicefluidly connected to the oxygen port. The oxygen concentrating devicemay include a first membrane electrode assembly (MEA) for the productionof oxygen from air. The first MEA may include a first electrode fluidlyconnected to ambient air, a second electrode spaced from the firstelectrode, the second electrode being fluidly connected to a first basinsuch that the first basin is fluidly connected to the oxygen port. Thefirst MEA further may include a first ion conducting membrane positionedbetween the first and second electrodes, a first conductive wireconnected to the first electrode, and a second conductive wire connectedto the second electrode, such that the application of a constantelectrical current through the first conductive wire to the secondconductive wire electrochemically concentrates oxygen on the secondelectrode from ambient air adjacent the first electrode.

The device further may include an oxygen consuming device fluidlyconnected to the oxygen port: the oxygen consuming device may include asecond MEA for the removal of oxygen from a gaseous mixture. The secondMEA may include a third electrode fluidly connected to the first basin,a fourth electrode spaced from the third electrode, a second ionconducting membrane positioned between the third and fourth electrodes,a third conductive wire connected to the third electrode, and a fourthconductive wire connected to the fourth electrode, such that theapplication of a constant voltage across the third conductive wire andthe fourth conductive wire electrochemically consumes oxygen from thefirst basin at the third electrode.

The device further may include a mechanical pump which comprises a pumpintake fluidly connected to the vacuum port, and a motor for driving themechanical pump such that the motor drives the mechanical pump toevacuate a gaseous mixture at an ambient temperature ranging fromapproximately 60° F. to approximately 100° F. and an ambient pressureranging from approximately 660 mmHg absolute to approximately 760 mmHgabsolute at a volumetric flow rate ranging from approximately 1 cc/minto approximately 2,500 cc/min while maintaining a vacuum at the pumpintake. The vacuum may range from approximately 1 mmHg to approximately680 mmHg.

The device further may include a pressure sensor and a microcontroller.The microcontroller may be electrically connected to the first MEA, thesecond MEA, the motor, and the pressure sensor. The microcontroller maybe configured to regulate operation of the wound care device in aplurality of operating modes which may include: a first operating modein which the first MEA delivers oxygen to the oxygen port at a rateranging from approximately 1 ml oxygen/hr to approximately 10 mloxygen/hr, at an ambient temperature of approximately 60° F. toapproximately 100° F. and an ambient pressure of approximately 760 mmHg;a second operational mode in which the second MEA consumes oxygen fromthe oxygen port at a rate ranging from significantly equal to or greaterthan 5 times the oxygen generating rate in the first operational state;and a third operational mode in which the mechanical pump evacuates agaseous mixture from the vacuum port at a volumetric flow rate rangingfrom approximately 1 cc/min to approximately 2,500 cc/min whilemaintaining a vacuum ranging from approximately 560 mmHg toapproximately 680 mmHg. The electronic wound care device may be combinedwith a dressing to deliver transdermal continuous oxygen therapy, lightsuction, negative pressure wound therapy, and combinations thereof to awound. The wound care device may be battery operated and portable.

DESCRIPTION OF THE DRAWINGS

In the accompanying drawings, which form a part of the specification andare to be read in conjunction therewith and in which like referencenumerals (or designations) are used to indicate like parts in thevarious views:

FIG. 1 is a partially exploded schematic view of an exemplary wound caredevice in accordance with the present invention;

FIG. 1A is a plan view of the interior side of the lid of the wound caredevice of FIG. 1;

FIG. 2 is a perspective view of another embodiment of a wound caredevice in accordance with the present invention;

FIG. 3 is a side view of the wound care device of FIG. 2;

FIG. 4 is a cross-sectional view of an embodiment of a dressing assemblyin accordance with the present invention;

FIG. 5 is a schematic plan view of the dressing assembly of FIG. 4;

FIG. 6 is a cross-sectional view of another exemplary dressing assemblywith a storage accessory for exudate in accordance with the presentinvention;

FIG. 7 is a schematic view of the dressing of FIG. 4 mounted on a legwound of a human patient;

FIG. 8 is a schematic view of transdermal oxygen flow through thedressing and across the wound of FIG. 5;

FIG. 9 is a schematic view of another exemplary device for deliveringNPWT and transdermal oxygen flow through a dressing and across a woundin accordance with the present invention;

FIG. 10 is a schematic view of yet another exemplary device fordelivering NPWT and transdermal oxygen flow through a dressing andacross a wound in accordance with the present invention;

FIG. 11 is a perspective view of another embodiment of a wound caredevice in accordance with the present invention;

FIG. 12 is another perspective view of the wound care device of FIG. 11with tubing for delivering NPWT, transdermal oxygen flow and othertreatment therapies to a dressing and across a wound in accordance withthe present invention;

FIG. 13 shows an exploded view of the wound care device of FIG. 11;

FIG. 14 shows a perspective view of components of FIG. 13;

FIG. 15 shows another perspective view of components of FIG. 13;

FIG. 16 is a plan view of an illustrative printed circuit board (PCB)and rear enclosure section of the device of FIG. 14;

FIG. 17 is a plan view of the MEA assembly and front enclosure sectionof the wound care device of FIG. 14;

FIG. 18 is a perspective view of the wound care device of FIG. 11 withthe front enclosure section removed;

FIG. 19 is a perspective view of the front enclosure section of FIG. 18and an exploded view of the MEA assembly;

FIG. 20 is a cross-sectional view of the wound care device of FIG. 11,along line 20-20;

FIG. 21 is a block diagram of an exemplary wound care apparatusincluding the wound care device of FIG. 11, an exemplary dressing forapplying wound care therapies to a wound, and an external container fortrapping and storing wound exudates;

FIG. 22 is schematic overview of an exemplary embodiment of softwarearchitecture for electronically controlling operation of the wound caredevice of FIG. 11;

FIG. 23A is the first of two portions of an exemplary flow diagram of afirst treatment mode of the wound care device of FIG. 11;

FIG. 23B is the second of two portions of the exemplary flow diagram ofFIG. 23A;

FIG. 24A is the first of two portions of an exemplary flow diagram of asecond treatment mode of the wound care device of FIG. 11;

FIG. 24B is the second of two portions of the exemplary flow diagram ofFIG. 24A;

FIG. 25 is a schematic diagram of primary unit process operations for anexemplary therapy cycle in accordance with the first treatment mode ofFIG. 23A and FIG. 23B.

FIG. 26 is a schematic diagram of primary unit process operations for anexemplary therapy cycle in accordance with the second treatment mode ofFIG. 24A and FIG. 24B.

DESCRIPTION

FIG. 1 shows an exploded view of an exemplary embodiment of a wound caredevice 50 in accordance with the present invention. The wound caredevice 50 may include a lid (or upper housing component) 52, an oxygenconcentrating device 54, a printed circuit board (PCB) 56, a batterypack 58, a vacuum pump 60, and a bottom enclosure (or lower housingcomponent) 62.

Referring to FIG. 1A, the lid 52 may include an exterior surface 64 andan interior surface 66. The interior surface 66 may include an oxygencollection chamber 68. The lid 52 further may include a tubular port 70on an exterior side wall portion of the lid. The tubular port 70 may bein fluid communication with the oxygen collection chamber 68. Theperimeter of the oxygen collection chamber may be encircled by one ormore adhesive strips 72. The adhesive strip(s) 72 may provide anattachment structure for securing the oxygen concentrating device 54 tothe lid. The adhesive strip(s) 72 also may cooperate with the oxygengenerating device to form a gas impermeable seal between the interiorsurface of the lid and the oxygen concentrating device such that theoxygen collection chamber is isolated from the housing interior.Although the oxygen concentrating device shown in FIG. 1 may be disposedon the lid, the oxygen concentrating device may be associated withanother part of the wound care device (e.g., an interior wall orcompartment) provided that the relevant operational features of theoxygen concentrating device remain in fluid communication with an oxygensource (e.g., the ambient atmosphere).

Referring to FIG. 1, the lid 52 may include openings or notches 74 toallow for entry of air into the housing interior. In addition, the lidmay include one or more projections 76 (e.g., locking tabs) which mayextend from the interior surface 66. Each of the projections may matewith a corresponding receptacle 78 on the bottom enclosure 62 to connectthe lid to the bottom enclosure. Additionally, the lid may be fixedlyconnected to the bottom enclosure to provide a tamper resistant seal.For example, the lid may be secured to the bottom enclosure byultrasonic welding. In another example, adhesive may be applied to thelocking tabs so as to bond the lid to corresponding receptacles on thebottom enclosure.

Referring to FIG. 2 and FIG. 3, the housing further may include a powerswitch 80. Although the power switch may be a button switch, anysuitable switching device may be used as long as the switching deviceprovides reliable operation and is resistant to inadvertent operation.In one embodiment, the switching device may require the application ofsignificantly greater force to deactivate (or power off) the device thanto activate (or power on) the device. In another embodiment, two handsmay be required to manipulate one or more safety locks in order todeactivate the device. In another embodiment, a tool may be required todeactivate the device. The power switch may be centrally located on oneside of the device, and the oxygen concentrating device 68 and oxygenport 70 may be located on an another side of the device.

As shown in FIG. 1, the bottom enclosure 62 may include a power and/orair supply chamber 82 for supplying air and electricity to the oxygenconcentrating device. For example, the base of the power and air supplychamber may be shaped to receive and hold a power supply for the device.Additionally, the middle and upper portion of the power and air supplychamber may be configured to securely accommodate a PCB upon which thecontrol circuit 112 for the device may reside. In the exemplaryembodiment, the PCB includes pairs of terminals 84 which clip toindividual batteries 86 and thus mechanically secure and electricallyconnect the power supply to the PCB and/or control circuit.

The bottom enclosure further may include a mechanical pump chamber 88.The mechanical pump chamber 88 may be physically separated from thepower and air supply chamber by a wall 90 so as to reduce the risk thatoperation of the mechanical pump may adversely impact oxygenconcentration and delivery processes. The mechanical pump chamber 88 maybe configured and dimensioned to securely receive the vacuum pump (e.g.,an electrically powered mechanical pump) 60 which may be used toevacuate gaseous substances and exudates from the wound environment. Themechanical pump chamber may include an exterior wall. The exterior wallmay include another tubular port 92. The other tubular port 92 may havea passageway 94 that extends from the tip of the tubular port to aninterior surface of the mechanical pump chamber. Further, the bottomenclosure 62 may include openings (e.g., notches or pin holes) 96 in theexterior walls of the mechanical pump chamber in order to vent pumpexhaust from the housing. Also, the bottom enclosure may includeattachment sites (e.g., receptacles for locking tabs) 78 for connectingthe lid to the bottom enclosure.

As shown in FIG. 2, the housing may include openings 98 for a number ofstatus indicators 100. For example, individual LEDs may be positioned ineach opening to signal operational modes or alarms.

Referring to FIG. 1, the oxygen concentrating device 54 may include amembrane electrode assembly (MEA) 102 for the electrochemical productionof oxygen from air or water. For example, an ion conducting membrane 104may be positioned between two electrodes 106 which in turn are connectedto a power source. Oxygen in ambient air may be reduced to water at aninterface region of the MEA between the cathode held at a reducingpotential and the membrane. The product water may be moved through themembrane to the anode held at an anodic potential, which oxidizes thewater back to oxygen while releasing protons at an interface regionbetween the anode and the membrane. The protons may move through themembrane to the cathode to make possible continued reduction of oxygenfrom air. Atmospheric nitrogen and carbon dioxide, however, which areelectrochemically inert under the reaction conditions required foroxygen reduction, are effectively rejected at the cathode. Accordingly,the reduction product of oxygen alone moves through the membrane,resulting in nearly 100% pure oxygen on the anode. An oxygen producingdevice for wound care is discussed in U.S. Pat. No. 7,429,252, which isincorporated herein by reference in its entirety.

The ion conducting membrane 104 may be any of a number of known ionconducting membranes which are capable of conducting protons and otherionic species. Suitable membranes may include various perfluorinatedionomer membranes which include a poly(tetrafluoroethylene) backbone andregularly spaced perfluorinated polyether side chains terminating instrongly hydrophilic acid groups. A preferred group of membranessuitable for use in the MEA include those containing sulfonic acidterminating groups on the side chains and available under the trademarkNafion® from E.I. Dupont Co. Nafion® is a perfluorinated polymer thatcontains small proportions of sulfonic or carboxylic ionic functionalgroups. Other suitable membranes may include partially fluorinatedmembrane materials and those based on hydrocarbon polymer backbones.

The electrodes 106 used in the membrane electrode assembly may be in theform of a mesh or a thin coating on the opposite surfaces of themembrane. In general, the electrodes may be made of any materials whichare electrically conductive and which will catalyze the reduction ofgaseous oxygen into water, provide a voltage differential across themembrane to move the oxygen containing species, and catalyze theoxidation of the product water to release oxygen. Suitable electrodematerials include, but are not limited to, platinum, iridium, rhodium,and ruthenium, as well as their alloys and oxides in a pure finelydivided form or as supported catalysts.

Referring to FIG. 1A, one method of making a membrane electrode assemblyincludes bonding a Pt/C electrode and a Pt black electrode 106 to eitherside of a Nafion® (or similar) membrane 104. The electrical connectionsfrom the electrodes 106 to the voltage source (or power supply) may beprovided through conducting end plates which may be made of graphite ormetallic material. To reduce weight and improve mobility of the device,a thin (e.g., 1-5 mil), electrically conducting and electrochemicallyinert wire is placed between the membrane and electrode during thebonding process, thereby making the electrical connection an integralpart of the membrane electrode assembly. Examples of such wires include:gold, Pt, gold or Pt plated or deposited Ta, or tungsten, and otherconducting materials such as carbon fiber.

In addition, a catalyst may be used to improve the electrochemicalproduction of oxygen in the above reactions. The addition of a catalystin one or both electrodes aids in overcoming kinetic reaction barriers.Preferably, a Pt—Ru, Pt—Ir, or similar noble metal alloy catalyst thatis poison resistant is used to coat the electrodes. The use of suchpoison resistant catalysts will prevent impurities introduced from theadhesive and other components of the device from reducing the catalystactivity and deactivating the device. Suitable non-limiting examples ofanode catalysts include Pt—Ir, Pt—Sn, and ternary combinations thereof.Suitable non-limiting examples of cathode catalysts include Pt—Ru/C,Pt—Sn, Pt—Ir, Pt—C, and ternary combinations thereof.

Each electrode further may be covered with a gas permeable/liquidimpermeable barrier layer 110. The gas permeable/liquid impermeablebarrier layer may be heat bonded to the electrode. These barrier layersmay protect the polymer membrane, which otherwise might be damaged bycontaminating foreign solids or liquids. Preferably, the gaspermeable/liquid impermeable barrier layer may be formed from ePTFE(i.e., expanded polytetrafluoroethylene).

The MEA electrodes 106 may be connected to the control circuit viaconductive wire(s) 108 embedded in each respective electrode. The amountof oxygen generated by the MEA 102 may be varied by changing the currentapplied to the electrodes. Typically, the device may produce betweenapproximately 1 ml oxygen/hr and approximately 50 ml oxygen/hr, morepreferably between approximately 3 ml/hr and approximately 10 ml/hr.

The mechanical pump 60 may be disposed in the mechanical pump chamber88. The mechanical pump may be a miniature diaphragm pump and may bedriven by a DC motor. At standard conditions, the pump may operate overa pressure range of approximately 0 kPa to 165 kPa and a vacuum range ofapproximately 0 mmHg to 500 mmHg absolute. The maximum unrestricted flowof the pump may be approximately 2.5 liters per minute (LPM). Operationof the mechanical pump may be controlled via pulse width modulation ofthe DC motor. One commercially available pump which may be suitable forthis application is a 2.5 LPM CTS Micro Diaphragm Pump manufactured byParker Hannifin Corporation.

The pump intake may be connected to a manifold that includes a pressuresensor, a check valve, and a liquid isolation filter (e.g, a micronfilter disc). The manifold, in turn, may be connected to the vacuum port92, which may be connected via external tubing to a waste canister andwound dressing. The pump discharge may be connected to a filter-mufflerto assist with filtration and provide noise reduction. The pumpdischarge may be released into the mechanical pump chamber 88. Asdescribed above, the mechanical pump chamber further may include anumber of notches or perforations 96 for releasing pump dischargeexhaust to the housing exterior.

The PCB 56 may include control circuitry for operating the oxygenconcentrating device, the mechanical pump, and the LED statusindicators. The control circuit also may include circuitry or devicesfor managing power from the power supply. The control circuit mayinclude a microprocessor and memory, a microcontroller, or an ASIC,along with other semiconductor devices and electronic components toprovide the desired functionality. Although the control circuit mayinclude a microprocessor or programmable microcontroller to provide thedevice with enhanced functionality (e.g., user selection and adjustmentof therapy settings), the control circuit may be implemented with basiccontrols and capabilities in order to provide a simple yet robust devicethat is suitable for use in acute care or home care settings.Preferably, the functionality of the device will include therapymonitoring based on measurements of MEA current usage as well as thepressure range of the mechanical pump vacuum intake.

For example, the device control system may monitor the oxygen deliveryrate and signal one or more status indicators should the MEA systemcease to operate according to the prescribed therapy. Also, the devicemay monitor the pressure of the mechanical pump vacuum intake in orderto determine whether there is a leak (i.e, the intake vacuum is lessthan the therapeutic range) or a blockage (i.e., the intake vacuum isgreater than the therapeutic range) in the dressing or vacuumapplication line. Also, the device control system may signal one or morestatus indicators that the device and dressing apparatus are operatingin accordance with the prescribed therapy.

The power supply 58 may include one or more electrical batteries 86.Preferably, the power supply may have a high energy density so as toprovide maximum power for minimum volume and weight. Non-limitingexamples of battery types that may be suitable for the power supplyinclude lithium-ion, alkaline and metal hydride batteries. Each batterymay be manufactured according to a predetermined life span. For example,without limitation, the batteries may be designed to supply powercontinuously to the wound care device for at least 5, 7, or 10 days.

Different sized batteries may be incorporated into a single oxygenproducing device. Other types of power sources include batteries, fuelcells, photovoltaic cells and supercapacitors in combination with one ormore of the above power sources. Although the control circuit, MEA,mechanical pump, and status indicators may be powered by one powersupply, independent power supplies may be provided for one or more ofthese components. Also, as previously described, the PCB may clipsecurely to the power supply.

Referring to FIG. 1 and FIG. 2, the oxygen port 70 and the vacuum port92 may conform to a standardized system of small-scale fluid fittingsthat are used for making leak-free connections between a male-taperfitting and its mating female part. For instance, the oxygen port andthe vacuum port may each include a Luer Lock fitting.

FIG. 4 shows an illustrative wound bed 114 prepared for NPWT andtransdermal continuous oxygen therapy (TCOT) with an exemplaryembodiment of a dressing 116 in accordance with the present invention.The TCOT/NPWT dressing 116 may include a wicking layer which abuts andcovers the wound bed 120. The wicking layer 118 may be made frommoisture-wicking synthetic fabric (e.g., Under Armour® or similarfabric). The wicking layer 118 may draw exudates away from the wound andaid in establishing contiguous flow of oxygen across the wound bed 120.The wicking layer may include an oxygen delivery manifold 122 toencourage topical delivery of oxygen to the wound. Additionally, thewicking layer may include a mixed gas and exudates removal manifold 124.This manifold may facilitate distributed oxygen flow across the woundbed, and may promote waste gas and exudates removal from the wound. Asshown in FIG. 5, the manifolds 122, 124 may be placed contra-laterallyabove the wound bed 120 to promote oxygen flow distribution and enhancecontact time. The oxygen delivery manifold 122 may be connected to afirst length of flexible tubing 126. The first length of flexible tubing126 may include a standardized fluid fitting (e.g., Luer Lock fitting)128 for connecting the other end of the flexible tubing to the oxygenport 70 of the wound care device 50. Similarly, the waste gas andexudates removal manifold 124 may be connected to a second length offlexible tubing 130. The second length of flexible tubing 130 mayinclude a standardized fluid fitting (e.g., Luer Lock fitting) 128 forconnecting the other end of the second length of flexible tubing to anintermediate waste canister or directly to the vacuum port 92 of thewound care device. The tubing may be made from a polymeric materialsuitable for use in hospital applications. Suitable materials for use inthe tubing include, but are not limited to, silicone, polyethylene,polypropylene, polyurethane and various other thermoplastics.

The dressing 116 further may include an absorbent layer 132 above themanifold and wicking layer 118. The absorbent layer 132 may holdexudates that are transported through the wicking layer. The absorbentlayer 132 may provide structural support for the wound, the manifold andthe first and second lengths of tubing. Additionally, the absorbentlayer 132 may provide a protective barrier for the wound bed againstphysical trauma or microorganisms. In one embodiment, the absorbentlayer may be gauze. In another embodiment, the absorbent layer may bepolyurethane foam.

The dressing 116 further may include a semi-occlusive layer 134. Thesemi-occlusive layer may be a sheet of transparent film. The sheet oftransparent film may include adhesive on one side to help create an airtight seal around the perimeter of the wound bed. The semi-occlusivelayer 134 may include penetrations for passage of the first and secondlengths of tubing. The penetrations may be located above the dressingmanifolds. Sealant may be applied around the penetration and theflexible tubing to form air tight seals. In one embodiment, the sheet offilm may be a Tegaderm® dressing manufactured by 3M.

FIG. 6 shows an illustrative wound bed prepared for NPWT and TCOTtherapy with another exemplary embodiment of a dressing 136 inaccordance with the present invention. This embodiment is similar to thedressing of FIG. 4 as described above. This embodiment, however,includes an integral bag 138 for storing waste exudates. The integralbag 138 may be flexible and possess a low profile to facilitate patientcomfort and mobility. The integral bag 138 may include internal spacers140 which may prevent flexible portions of the bag from collapsing andoccluding exudates and waste gas flow under negative pressure.

FIG. 7 shows a schematic representation of the dressing of FIG. 6applied to a leg wound of a patient. The dressing 136 may be orientedsuch that the oxygen delivery manifold 122 is closer to the patient'sknee 142 and the mixed gas and exudates removal manifold (or vacuumapplication manifold) 124 is closer to the patient's ankle 144. Thedressing 136 and flexible tubing 126, 128 may be secured with a strap146 at the top end and the bottom end of the dressing assembly to allowthe patient to ambulate. Additional straps may be used to secure thevacuum supply tubing and the oxygen delivery tubing along the length ofthe patient's leg. The straps may have fastening elements for providingan adjustable fit. The fastening elements may be hook and loop fasteners(e.g., Velcro® strips).

FIG. 8 shows a schematic representation of mass flow 148 across anexemplary wound 120 being treated with NPWT and transdermal oxygentherapy. During one mode of therapy, oxygen at a maximum rate ofapproximately 3 cc/hr to approximately 4 cc/hr may be continuouslydirected to the wound bed by the oxygen delivery manifold. Concurrently,the vacuum application manifold may apply negative pressure to the woundbed to create a maximum return-gas flow rate of approximately 1 cc/hr.It is believed that the balance of oxygen delivered to the wound bed maybe naturally absorbed or consumed by tissue in or around the wound.During application of this therapy, the head space of the wound insidethe dressing assembly may stabilize at an oxygen concentration in therange of approximately 20 percent to 75 percent. Preferably, however,the head space of the wound inside the dressing assembly may stabilizeat an oxygen concentration of approximately 70 percent. The non-oxygenhead space gases in the dressing may include tissue off gases (e.g.,carbon dioxide) from natural processes such as respiration from thewound.

Oxygen delivery pressure may adjust to whatever pressure may be neededto accommodate the generation rate of oxygen determined by the currentflow. Oxygen delivery pressure to the dressing may be slightly greaterthan the pressure in the headspace of the wound environment in order forthe oxygen to flow to the wound. For example, the oxygen deliverypressure may reach an average pressure of approximately 680 mmHgabsolute because the pressure in the headspace of the wound environmentmay range from approximately 660 mmHg to 680 mmHg. The vacuum level atthe wound may be adjusted by the control system to achieve the desiredtherapeutic conditions. In this operable configuration, the MEA mayoperate under a constant current mode to enable oxygen generation. Forexample, the MEA may generate oxygen at a rate of 3 cc/hr. Although, thecontroller may vary the level of the current in order to adjust the rateof oxygen production, the MEA may be operated at a constant current sothe flow of oxygen to the wound may be maintained by the backpressure ofoxygen in the MEA assembly, the vacuum applied to the wound space by themechanical pump, and respiration of the wound. The control system mayvary the vacuum level by activating the mechanical pump. The mechanicalpump speed further may be controlled through pulse width modulation.

Periodically, in another mode of therapy, the mechanical pump speed maybe set to zero and the polarity of the MEA reversed. Under theseconditions, the MEA may operate under constant voltage to generate avacuum at the oxygen delivery manifold. The vacuum generated by the MEAmay range from approximately 1 mmHg to approximately 50 mmHg. Thereduction in negative pressure applied by the MEA in this mode oftherapy may benefit healing processes in the wound by temporarilyreducing wound tissue strain. A wound healing device for the applicationof oxygen and the removal of wound exudates is discussed in U.S. Pat.No. 8,088,113, which is incorporated herein by reference in itsentirety.

FIG. 9 shows a schematic diagram of another embodiment of a wound caredevice 152 connected to a dressing 116 for applying transdermal oxygentherapy and negative pressure wound therapy to a wound 150. Theapparatus may include an MEA 102, a vacuum pump 60, and a housing 154for these components. The housing may include a gas/liquid barrier 156between the MEA 102 and the mechanical pump 60. The gas/liquid barrier156 may divide the housing 154 into two chambers. The first chamber 158of the device may include the MEA (or cell) and oxygen port. The MEA mayinteract with air outside the housing to produce nearly pure oxygen inthe first chamber. The second chamber 160 of the device may include theintake of the vacuum pump and the vacuum port 92. The mechanical pumpintake may include a fitting that includes a pressure sensor and aliquid impermeable filter. The second chamber may include a liquid trap162 for storing or containing exudates that have been evacuated from thewound 150 and drawn into the housing 154 under negative pressure. Acheck valve 164 connecting the two chambers 158, 160 may allow gas flowfrom the second chamber 160 to the first chamber 158. The check valve164 may be a flap valve. The oxygen port 70 may be connected viaflexible tubing 128 to a dressing 116 for delivering oxygen to the wound150. The vacuum port 92 may be connected via flexible tubing 130 to thedressing to apply negative pressure to the wound 150. The liquid trap162 may operate based on mechanical principles or chemical-mechanicalprinciples. The liquid trap 162 may be designed to operate independentlyof the device's orientation. In another embodiment, the treatment deviceof FIG. 9 may be designed with the exudates trap on the outside of thehousing. An external exudates trap may be removable from the housing.

FIG. 10 shows a schematic diagram of another device 166 that may be usedwith a dressing 116 to simultaneously apply transdermal oxygen therapyand negative pressure wound therapy to a wound. The device may includetwo MEAs 168, 170, a mechanical pump 172, and a housing 154. The device166 may include a first MEA 168 that concentrates oxygen in a firstinternal compartment 174 of the housing. The first internal compartment174 may be connected to an oxygen port 70 for delivery to the wound. Thevacuum pump intake 92 may be connected a second internal compartment 176in the housing. The second internal compartment 176 may be connected toa vacuum port 92 for applying negative pressure to the wound. The secondMEA 170 may be configured to consume oxygen from the exudates reservoir162 and contribute to, or when operating alone create, a negativepressure in the second internal compartment 176. A passage 178 mayconnect the second internal compartment 176 to the third internalcompartment 180 adjacent the second MEA 170. In this embodiment, one MEA168 may be dedicated to generating oxygen for the oxygen port 70 andanother MEA 170 may be dedicated to generating negative pressure in thesecond compartment 176 and vacuum port 92. The second internalcompartment 176 further may include a drain 182 for removing exudateevacuated from the wound via negative pressure. The second internalcompartment 176 may be configured to store exudates independent of thehousing orientation. The device may be connected to a dressing viaflexible tubing.

FIG. 11 shows another embodiment of a wound care device 184 inaccordance with the present invention. The wound care device 184 mayinclude an exterior housing 186. The housing may include two or moresections. The sections may be connected to form an enclosure for holdingand containing internal components of the wound care device. In thisembodiment, the housing may include two sections 186 a, 186 b which maybe secured together to form a tamper resistant, water resistantenclosure.

The enclosure may house process equipment, electronic controls,communication devices, and power supply equipment that enable a mobileand self-contained wound care device which is capable of providing aportable oxygen supply and a portable vacuum supply for administeringtransdermal oxygen therapy, NPWT, light wound suction, and otherprescribed wound care therapies involving combinations thereof.

The housing (or enclosure) 186 may include an oxygen supply port 70, avacuum supply port 92, a vacuum pump exhaust port 188, and a powerswitch 190. One or more of the ports may include a Luer lock fitting.Also, the enclosure includes three status indicator windows 192 a, 192b, 192 c. One status indicator window 192 a may include a light pipe foran LED that signals a low battery condition (i.e., a battery lowindicator). A second status indicator window 192 b may include anotherlight pipe for another LED that signals whether there is a leak orblockage in the dressing or vacuum application line (i.e., pressureexcursion indicator). The third status indicator window 192 c mayinclude yet another light pipe for yet another LED that signals whetherthe device is on and/or operating in accordance with the prescribedwound care therapy.

The enclosure 186 may be designed to possess a low profile configurationthat prevents entanglement with other bodies or external objects. Thus,the enclosure may have a length (L) and a width (W) of approximatelyequal dimension, and a height (H) that is less than the other twodimensions. For example, the housing may have a length of approximately2.75 inches, a width of approximately 2.625 inches, and a height ofapproximately 1.43 inches. The external features of the housing may besmooth and rounded.

As shown in FIG. 12, the wound care device may be connected to aretaining clip (or holster) 194 which may be secured to a belt or strap196 for mounting on (or near) a patient. For example, the housing andretaining clip may form a press-fit connection. With respect to mountingthe wound care device 184 within the retaining clip 196, the enclosure186 may be considered to have a front side 198, a rear side 200, a rightside 202, a left side 204, a top side 206, and a bottom side 208. Therear side 200 of the enclosure may face the retaining ring clip 194. Thefront side 198 of the enclosure may face away from the retaining clip.The top side 206 of the enclosure may include the power switch, and thebottom side 208 of the enclosure may include the oxygen supply port 70and the vacuum supply port 92. The left side 204 of the enclosure mayinclude the vacuum pump exhaust 188.

The enclosure 186 may be formed from plastic, a reinforced polymermaterial, metal alloy or other strong durable material suitable for usein a medical device. For example, the enclosure may be formed from ABS(acrylonitrile butadiene-styrene) plastic.

Referring to FIG. 13, the wound care device may include a frontenclosure section 186 a, a printed circuit board 210, a fixed powersupply 212, a rear enclosure section 186 b that includes a replaceablepower supply compartment 214, a replaceable power supply 216 and a cover218 for the replaceable power supply compartment. The wound care device184 further may include a retaining clip 194.

As shown in FIG. 14, the front enclosure section 186 a may include anoxygen supply port 70, an MEA assembly chamber 220, three light pipes222, a vacuum pump chamber 224, and four locking tabs 226 for securingthe front enclosure section to the rear enclosure section. A wall 228may separate the MEA assembly chamber 220 from the vacuum pump assemblychamber 224. The front enclosure section further may include a cutout230 a in the left side wall and another cutout 230 b in the bottom sidewall.

Referring to FIG. 16, the PCB 210 may include a power switch 232 and amechanical slide 234 for activating the power switch, process controlcircuitry 236 including a microcontroller 238, a contact spring assembly240 for electrically connecting the control circuitry to the MEAassembly, a vacuum pump and motor assembly 242, a vacuum pump intake 244and associated tubing 246, a vacuum pump discharge 248 and associatedfittings and tubing 250, a pressure sensor assembly 252 and associatedtubing 254, and dedicated MEA power supply terminals 256 (see FIG. 15).As shown in FIG. 15, the MEA power supply terminals 256 may beconfigured and dimensioned for a standard or custom battery type. ThePCB 210 further may include a dedicated power supply circuit and a powersupply (i.e., coin battery) for regulating operation of the wound caredevice.

Referring to FIG. 14, the rear enclosure section 186 b may include anMEA power supply storage compartment 258, a vacuum pump exhaust port 188and connector fitting 260, a vacuum supply port 92 and connector fitting262, as well as power supply cradles 264, and receptacles for receivingthe front enclosure section locking tabs 266. As shown in FIG. 15, therear enclosure section 186 b further may include a storage compartment214 (and cover), as well as terminals 268 for a dedicated vacuum pumppower supply. The vacuum pump power supply terminals 268 may beconfigured and dimensioned for a standard or custom battery type. Therear enclosure section 186 b further may include a smooth, flat recessedsurface 270 for receiving one or more product labels.

FIG. 16 shows a plan view of the PCB 210 mounted in the rear enclosuresection 186 b. The vacuum pump 242 is in fluid communication with thevacuum supply port 92. The vacuum pump intake port 244 is connected viatubing 246 to one branch of a T-fitting 272 that is connected to thevacuum supply port 92. The other branch of the T-fitting 272 isconnected to a pressure sensor assembly 252 by a conduit 254. Theconduit 254 may be flexible tubing. The vacuum pump discharge port 248is in fluid communication with the vacuum pump exhaust port 188. Thevacuum pump discharge port 248 is connected to a fitting that via tubing250 is connected to another fitting that is connected to the vacuum pumpexhaust port 188. Also, status indicator LEDs 274 may be positioned onthe PCB. Each LED 274 may interact with a dedicated light pipe 222 tovisually signal the status of selected operational processes. The PCB210 further may include, without limitation, a set of contacts 276 forprogramming the microcontroller, as well as one or more power circuits.Additionally, the PCB 210 may include memory, a data bus, and/orwireless communication capabilities.

Referring to FIG. 19, the MEA assembly 278 may be attached to theinterior surface of the front enclosure section 186 a. The interiorsurface of the front enclosure section may include two basins (orsink/recesses) 280 a, 280 b. Each basin 280 a, 280 b may be positionedunder one MEA 282 a, 282 b. Each basin may further include a sidewall284 a, 284 b. One sidewall 284 a may be connected to the other sidewall284 b by an intermediate passage 286. Further, the other sidewall 284 bmay be connected to the oxygen supply port 70 by a distribution passage288. Preferably, the intermediate passage 286 and the distributionpassage 288 are aligned to facilitate fluid communication between thesinks 280 a, 280 b and the oxygen supply port 70.

The MEA assembly 278 may include an inert gasket 290 disposed betweenthe MEAs 282 a, 282 b and the front enclosure section 186 a. The gasket290 may have holes 292 a, 292 b that conform to the shape and locationof the sinks 280 a, 280 b, as well other holes 294 that are compatiblewith the MEA assembly. The MEAs 282 a, 282 b then may be clamped to thefront enclosure section with a frame (or plate) 295. The frame 295 alsomay conform to the shape and location of the sinks 280 a, 280 b and mayinclude holes 296 (for receiving fasteners 297) that present a patternthat conforms to the other holes 294. Further, the MEA electrodes may beconnected via conductive wires 298 a, 298 b, 298 c, 298 d to a PCBlanding pad 300. As shown in FIGS. 17 and 18, the PCB landing pad 300may be secured with screws 302 to a dedicated seat 304 located adjacentto the MEAs.

As shown in FIG. 20, the electrical contacts 298 a, 298 b, 298 c, 298 don the landing pad 300 are situated above the spring loaded contactassembly 240. When the front enclosure section 186 a and the rearenclosure section 186 b are joined, the electrical contacts 298 a, 298b, 298 c, 298 d on the landing pad 300 are pressed against therespective contacts on the spring loaded contact assembly 240 toelectrically connect the MEAs 282 a, 282 b to electrical circuitry onthe PCB 210.

Referring to FIG. 21, the wound care device 184 may include an oxygensupply MEA 282 a, an oxygen consuming MEA 282 b, a vacuum pump and motor242 a, 242 b, a pressure sensor 252, a power supply and electroniccontrols, LEDs 222, and input/output devices 276. A dressing 116 may beconnected to the wound care device 184 to provide treatment for a wound114. A canister (or exudate trap) may be positioned between the dressingand the vacuum supply port of the vacuum pump to collect and storeexudates from the wound. The canister may be combined with the dressing136 as shown in FIG. 6. A pressure sensor 252 may be positioned at thevacuum supply port. The pressure sensor 252 may be part of the controlcircuitry that regulates the operation of the wound care device. Forexample, the pressure sensor 252 may be used by a control circuit tomonitor the pressure applied to the dressing and to adjust (or control)operation of the vacuum pump 242 a to maintain a desired therapeuticvacuum level inside the dressing (e.g., 80-100 mmHg). Operation of thevacuum 242 a pump may be regulated by the control circuit, as well as byduty cycle requirements as determined by any local process controls. Theoxygen supply MEA 282 a may be operated by a circuit that provides aconstant current across the membrane electrodes. By contrast, the oxygenconsuming MEA 282 b may be operated by a circuit that provides constantvoltage across the MEA electrodes. The power supply may includeindependent sources and circuits for the vacuum pump motor 242 b and theMEAs 282 a, 282 b. The power supply for the control circuit that mayregulate operation of the wound care device as a whole may beindependent, as well. Still, the power supply for the control circuitmay be derived from one of the other two power supplies. The statusindicator LEDs 222 and any other input/output devices may be connectedto the control circuit as well. Preferably, the control circuit willinclude a microcontroller 238 that has been pre-loaded with firmware toregulate operation of the wound care device. Thus, the device 184 may beloaded with a standard firmware program for one of a number of woundcare therapies. Still, the firmware may be updateable. Accordingly, apatient specific modality of treatment may be prescribed by a doctor andloaded into the device.

Referring to FIG. 22, the exemplary software architecture overview 308for regulating operation of the wound care device 184 may include thefollowing configuration. The wound care device 184 may be turned on byclosing a mechanical switch. The wound care device may then power on 310and activate a state machine. The state machine may be amicrocontroller. During a typical cycle of the state machine, the statemachine may connect with the following components: a timer 312, amanufacturer system check 314, a pressure monitor 316, an MEA control318, a vacuum pump control/monitor 320, a battery monitor 322, and LEDstates 324. For example:

1. A timer may be initiated at startup and may be updated during eachcycle of the state machine. If the wound care device has been operatingfor seven days, the microcontroller may disable the device. The timermay track “on” time in blocks of time. For example, without limitation,each block of time may be 10 minutes.

2. A manufacturer system check may be initiated at startup and may beupdated during each cycle of the state machine. The manufacturer systemcheck would verify operation of system components (e.g., the MEAs andvacuum pump) and then light the appropriate LED based on the status ofthe check.

3. A pressure monitor check may be initiated at startup and may beupdated during each cycle of the state machine. The pressure sensor maybe positioned near the vacuum pump intake or the MEA oxygen supplyoutlet. If the wound care device is operating properly, the measuredvalue at these two locations should be related and close in value.Alternatively, the pressure monitor check may monitor the pressure nearthe vacuum pump intake and the MEA oxygen supply outlet.

4. MEA control may regulate operation of the MEAs. The two MEAs may beoff (or non-operational), in an oxygen generation mode in which one MEAoperates on constant current, or in an oxygen consuming mode in whichthe other MEA operates on constant voltage.

5. Pump control may regulate operation of the vacuum pump via the motor.The pump may be off (or non-operational), or on but subject to dutycycle limitations. The pump may be controlled using a pulse widthmodulation voltage supply. The pump operation may be regulated toprovide a target pressure of between 80-100 mmHg vacuum at the vacuumpump inlet.

6. The battery voltage of each power supply may be monitored. If thevoltage of the replaceable batteries falls below a certain level, an LEDwarning light may be lit.

7. LEDs may be lit to reflect the operating status of the wound caredevice.

FIG. 23A and FIG. 23B show a schematic flow chart 326 for an exemplaryTCOT and NPWT treatment mode that may be used to regulate operation ofthe wound care device. The treatment mode may start when the wound caredevice is powered on 328. The system timer may be updated 330, and thevalue of the system timer may be compared to a pre-set value 332 thatdetermines the duration of the treatment cycle. In FIG. 23A the durationof the treatment cycle is seven days. If the value of the system timeris seven days or more, than an LED warning 334 is given to provide avisual signal that the treatment cycle has been completed. The woundcare device then may be disabled 336. By contrast, if the value systemtimer is less than seven days, then the replaceable power supply isevaluated 338 to determine whether the batteries should be replaced. Forexample, the voltage of the replaceable power supply may be measured andif the measured value of the replaceable power supply voltage is lessthan a pre-set value, then an LED warning 340 is given to provide avisual signal that the batteries in the replaceable power supplycompartment should be replaced. The visual signal may be cleared 342 byreplacing the batteries in the replaceable power supply. After the LEDwarning 340 has been cleared 342 or if the batteries did not need to bereplaced, then a system check 344 may be undertaken. If the system check344 determines that the system is not OK (e.g., has not passed therequired system checks), then an LED warning 334 is given to provide avisual signal that the system is not OK. The wound care device then maybe disabled 336. If, however, the system check 344 determines that thesystem is OK (e.g., has passed the required system checks), then woundtreatment processes may be monitored and regulated.

Referring to FIG. 23B, the monitoring and regulation of wound treatmentprocesses 326 amay start with an evaluation of the pressure 346 of thedressing headspace, which may be measured in the vacuum line, at thewound site, or in the oxygen delivery line. If the measured pressure ishigher than the desired range, then the vacuum pump is turned on 348.For example, the pressure measurement may be collected from a pressuresensor in the vacuum line at (or near) the vacuum pump intake. If thepressure measurement indicates that the vacuum level in the dressing isnot low, then no action is taken with the pump. After assessing and/orregulating the operation of the vacuum pump, the treatment program mayassess and/or regulate operation of the MEAs.

An oxygen generation timer may be pre-set to a value T_(OG) thatdetermines the duration of oxygen generation in a dual action treatmentsub-cycle. The oxygen generation timer may be evaluated to determinewhether the oxygen generation timer is done 350. If the oxygengeneration timer has not expired, then one MEA may be operated in aconstant current setting 352 to concentrate oxygen for delivery to thedressing; whereas, the other MEA may be off. The system timer may beupdated 330 and the subroutine continued. By contrast, if the oxygengeneration timer has expired, then the other MEA may be operated in aconstant voltage setting 354 to consume oxygen from the dressing. Theother MEA may be operated in a constant voltage setting until an oxygenconsumption timer expires 356. The oxygen consumption timer may bepre-set to a value T_(OC) that determines the duration of oxygenconsumption in the dual action sub-cycle (DASC). After the oxygenconsumption timer expires, the oxygen generation timer and the oxygenconsumption timer may be reset 358. Then the system timer 330 may beupdated, and the subroutine continued.

FIG. 25 depicts the operating state of the vacuum pump, oxygengenerating MEA, and oxygen consuming MEA for an exemplary TCOT and NPWTdual action sub-cycle in accordance with the schematic flow chart ofFIG. 23A and FIG. 23B, where the oxygen generation timer value T_(OG) isset to a value of 55 minutes and the oxygen consumption timer value isset to a value of 5 minutes. The exemplary TCOT and NPWT dual actionsub-cycle would be completed every hour for the duration of thetreatment cycle, which in this example is seven days.

FIG. 24A and FIG. 24B show a schematic flow chart 360 for an exemplaryTCOT and intermittent NPWT treatment mode that may be used to regulateoperation of the wound care device. The treatment mode may start whenthe wound care device is powered on 362. The system timer may be updated364, and the value of the system timer may be compared 366 to a pre-setvalue that determines the duration of the treatment cycle. In FIG. 24Athe duration of the treatment cycle is seven days. If the value of thesystem timer is seven days or more, then an LED warning 368 is given toprovide a visual signal that the treatment cycle has been completed. Thewound care device 184 may then be disabled. By contrast, if the valuesystem timer is less than seven days, then the replaceable power supplyis evaluated 370 to determine whether the batteries should be replaced.For example, the voltage of the replaceable power supply may be measuredand if the measured value of the replaceable power supply voltage isless than a pre-set value, then an LED warning 368 is given to provide avisual signal that the batteries in the replaceable power supplycompartment should be replaced. The visual signal may be cleared 372 byreplacing the batteries in the replaceable power supply. After the LEDwarning 368 has been cleared, or if the batteries did not need to bereplaced, a system check may be undertaken 374. If the system check 374determines that the system is not OK (e.g., has not passed the requiredsystem checks), then an LED warning 376 is given to provide a visualsignal that the system is not OK. The wound care device 184 may then bedisabled 378. If, however, the system check 374 determines that thesystem is OK (e.g., has passed the required system checks), then woundtreatment processes may be monitored and regulated.

Referring to FIG. 24B, a vacuum interval timer may be pre-set to a valueT_(VINT) that determines the interval between the start of the MEAassembly dual action sub-cycle (DASC) and the start of NPWT.Additionally, a vacuum mode timer may be pre-set to a value T_(VAC) thatdetermines the duration of NPWT in this exemplary prescribed therapeuticsub-cycle (PTSC).

The vacuum interval timer may be evaluated to determine whether thevacuum interval timer has expired 380. If the vacuum interval timer hasnot expired and the oxygen generation timer has not expired 382 then oneMEA may be operated in a constant current setting 384 to concentrateoxygen for delivery to the dressing. The system timer may be updated 364and the subroutine continued. On the other hand, if the vacuum intervaltimer has not expired 380, but the oxygen generation timer has expired382, then the other MEA may be operated in a constant voltage setting386 to consume oxygen from the dressing. The other MEA may be operatedin a constant voltage setting until an oxygen consumption timer expires388. The oxygen consumption timer may be pre-set to a value T_(OC) thatdetermines the duration of oxygen consumption in the MEA assemblysub-cycle (MASC). After the oxygen consumption timer expires, the oxygengeneration timer and the oxygen consumption timer may be reset 390. Thenthe system timer may be updated 364, and the subroutine continued.

If the vacuum interval timer has expired 380, however, the monitoringand regulation of wound treatment processes may start with an evaluationof the pressure of the dressing headspace, which may be measured in thevacuum line, at the wound site, or oxygen delivery line. If the measuredpressure is higher than the desired range, the vacuum pump is turned on392. For example, the pressure measurement may be collected from apressure sensor in the vacuum line at (or near) the vacuum pump intake.If the pressure measurement indicates that the vacuum level in thedressing is not low, then no action is taken with the pump. Themonitoring and regulation of the vacuum pump operation may continueuntil the vacuum mode timer expires 394. After the vacuum mode timerexpires 394 the oxygen timers are reset 390, as the oxygen generationtimer 382 has expired and the oxygen consumption timer 388 has expired.Then the system timer 364 may be updated, and the subroutine continued.

FIG. 26 depicts the operating state of the vacuum pump, oxygengenerating MEA, and oxygen consuming MEA for an exemplary TCOT andintermittent NPWT sub-cycle in accordance with the schematic flow chartof FIG. 24A and FIG. 24B, where the oxygen generation timer value T_(OG)is set to a value of 44 minutes, the oxygen consumption timer value isset to a value of 1 minute, the vacuum interval timer is set to a valueof 45 minutes, and the vacuum mode timer is set to 15 minutes. Thisexemplary prescribed therapy sub-cycle would be completed every hour forthe duration of the treatment cycle, which in this example is sevendays.

In use, the foregoing devices and dressings may be combined to form anapparatus that may be used to provide negative pressure wound therapyand transdermal oxygen therapy to a wound. The apparatus may include atreatment device which houses an MEA oxygen concentrator and themechanical pump for delivering negative pressure, as well as a dressingthat includes inlet and outlet connections terminating in a manifold tofacilitate a substantially uniform flow of oxygen across the treatmentarea. The treatment devices may be disposable and may be designed for asingle clinical use. For example, the treatment device may be designedto operate continuously for at least 7 days. In another example, thetreatment device may be designed to operate continuously for at least 15days. In another example, the treatment device may be designed tooperate continuously for at least 30 days. And, in yet another example,the treatment device may be designed to operate continuously for atleast 60 days. The dressings and tubing may be adapted for usespecifically with the treatment device(s). As these consumables may bereplaced on an as needed basis, the dressing(s) and tubing may beavailable in individually sealed sterile packaging.

Generally, treatment of a wound involving negative pressure woundtherapy and transdermal oxygen therapy may be ordered by a physician.After the wound is inspected, cleansed and otherwise appropriatelyprepared for treatment, the dressing may be placed in the wound and thesurrounding area may be covered with the semi-occlusive layer. Twoopenings may be created in the semi-occlusive layer above thedressing(s) vacuum and oxygen supply manifolds, respectively. The tubingassociated with each manifold then may be passed through the respectiveopenings. Alternatively, the dressing and semi-occlusive layer may beprovided in an integral configuration. Sealant may be used to provide anairtight seal around the tube penetrations in the semi-occlusive layer.The oxygen supply tubing may be connected to the oxygen port of thedevice. The vacuum supply tubing may be connected to the vacuum port ofthe device.

The treatment device may be powered on by depressing (or otherwiseactivating) the power button. The device may undergo a start up processthat includes a diagnostic assessment which confirms that the device isoperating properly, that the apparatus does not include a leak orblockage, and that the differential pressure between the oxygen supplyand vacuum supply is in the expected range of a fresh dressing. Theresults of the diagnostic assessment may be reported to the statusindicators and any correction of any identified adverse conditions maybe required before a treatment operation may commence.

During treatment, the MEA may be operational (“on”) or nonoperational(“off”). When the MEA is on and in a first operational mode, the MEA maybe concentrating atmospheric oxygen for delivery to the oxygen supplyport at a rate ranging from approximately 1 cc/hour to approximately 100cc/hour. The concentrated oxygen, which may be nearly pure, may bedelivered to the dressing and wound environment. By contrast, when theMEA is on and in a second operational mode, the MEA may be consumingoxygen from the dressing headspace at a very rapid rate (e.g. a rateranging from about 5 to about 50 times greater than the respectiveoxygen generation rate of the MEA under normal operating conditions).Generally, the oxygen consumption rate of the MEA may be related to thecurrent delivering capability of the power supply and the amount ofoxygen available for consumption. In view of the above, consumption ofoxygen by the MEA may result in the application of a vacuum to thedressing and wound site. The vacuum applied by the MEA to the wound sitemay range from approximately 1 mmHg to approximately 50 mmHg.

Additionally, the mechanical pump may be operational (“on”) ornonoperational (“off”). When the mechanical pump is on and in a thirdoperational mode, the mechanical pump may evacuate waste gas and liquidexudate at a rate in the range of approximately 1 cc/min toapproximately 2,500 cc/min. The vacuum applied to the dressing manifoldmay range from approximately 560 mmHg to approximately 680 mmHg.

The treatment devices may initiate a first treatment modality in whichone MEA is in the first operational mode and the mechanical pump is inthe third operational mode. For example, the MEA may supply oxygen tothe dressing at a rate of approximately 3 cc/min and the mechanical pumpmay be operationally controlled to apply a vacuum of approximately 100mmHg to the dressing and a maximum throughput (or flow rate) ofapproximately 1 cc/hour. The balance of the supplied oxygen (i.e., 2cc/hour) may be consumed by the wound and adjacent skin. In the firstoperational mode, the supply of oxygen is controlled by the amount ofcurrent passing between the MEA electrodes. In the third operationalmode, the applied vacuum may be set by the pump speed which may becontrolled through pulse width modulation. Alternatively, the pump speedmay operate at a set point and the pump operation may be regulated witha microprocessor controlled power switch capable of regulating the “on”and “off” timing intervals according to the programmed values.Accordingly, the first treatment modality may apply NPWT and transdermaloxygen therapy to the wound.

Treatment administered using the devices of FIG. 1 or FIG. 9 mayinitiate a second treatment modality with the MEA in the secondoperational mode and the mechanical pump on standby. In the secondtreatment modality, the polarity of the MEA may be switched, and aconstant voltage may be applied across the MEA electrodes. By contrast,treatment administered by the device of FIG. 10 and FIG. 11 may includean MEA dedicated to supplying negative pressure to the wound.Accordingly, the second treatment modality may apply lower levels ofsuction to the wound than applied during NPWT.

The treatment devices may initiate a third treatment modality with anoxygen concentrating MEA in the first operational mode and themechanical pump on standby. Accordingly, the third treatment modalitymay apply transdermal oxygen therapy to the wound.

The treatment devices may initiate a fourth treatment modality with anoxygen concentrating MEA in standby and the mechanical pump in the thirdoperational mode. Accordingly, the fourth treatment modality may applyNPWT to the wound.

The foregoing treatment modalities may be combined into sequences oftreatment (or therapies). The sequence of treatment modalities appliedby the devices to a wound may be programmed into the functionality ofthe device and manually set or implemented by a user of the device.Accordingly, the device may allow for the application of a widecombination of therapies for treating wounds in a mobile device that maybe adapted to the therapeutic and clinical needs of the patient.

While it has been illustrated and described what at present areconsidered to be a preferred embodiment of the present invention, itwill be understood by those skilled in the art that various changes andmodifications may be made, and equivalents may be substituted forelements thereof without departing from the true scope of the invention.For example, in some treatment therapies where the vacuum pump and theoxygen consuming MEA do not operate at the same time, the oxygenconsuming MEA may be connected to the vacuum port and segregated fromthe oxygen generating MEA. Additionally, features and/or elements fromany embodiment may be used singly or in combination with otherembodiments. Therefore, it is intended that this invention not belimited to the particular embodiments disclosed herein, but that theinvention include all embodiments falling within the scope and thespirit of the present invention.

What is claimed is:
 1. A wound care device comprising: a vacuum port; anoxygen port; an oxygen concentrating device in fluid communication withthe oxygen port, the oxygen concentrating device further comprising: atleast one membrane electrode assembly (MEA) comprising: a firstelectrode fluidly connected to ambient air, a second electrode spacedfrom the first electrode, the second electrode in fluid communicationwith a first basin, and wherein said first basin is in fluidcommunication with said oxygen port, a first ion conducting membranepositioned between the first electrode and the second electrode, a firstconductive wire connected to the first electrode, and a secondconductive wire connected to the second electrode, such that theapplication of a constant electrical current through the firstconductive wire to the second conductive wire electrochemicallyconcentrates oxygen on the second electrode from ambient air adjacentthe first electrode; a pump comprising a pump intake fluidly connectedto the vacuum port, and a motor for driving the pump, such that themotor drives the pump to evacuate a gaseous mixture while maintaining avacuum at the pump intake; a pressure sensor in fluid communication withthe vacuum port; a microcontroller electrically connected to the atleast one MEA, the motor, and the pressure sensor, the microcontrollerbeing configured to regulate operation of the wound care device in aplurality of operational modes, said operational modes furthercomprising: a first operational mode in which the first MEA deliversoxygen to the oxygen port at a rate ranging from 1 ml oxygen/hr to 10 mloxygen/hr, and at atmospheric pressure; a second operational mode inwhich the pump evacuates the gaseous mixture from the vacuum port; andan enclosure for housing said at least one MEA and said pump, whereinthe enclosure comprises a cover section and a base section, and whereinsaid at least one MEA and said oxygen port are connected to the coversection and said pump and said vacuum port are connected to the basesection.
 2. The device of claim 1, wherein said motor drives the pump toevacuate the gaseous mixture at a volumetric flow rate ranging from 1cc/min to 2,500 cc/min, and at a vacuum ranging from 1 mmHg to 680 mmHg.3. The device of claim 1, wherein said second operational mode furthercomprises operating said pump to evacuate a gaseous mixture from saidvacuum port at a volumetric flow rate ranging from 1 cc/min to 2,500cc/min while maintaining a vacuum ranging from 560 mmHg to 680 mmHg. 4.The device of claim 1, wherein the first basin comprises a recess in thecover section.
 5. The device of claim 4, further comprising a secondbasin adjacent the first basin.
 6. The device of claim 5, furthercomprising an intermediate passage fluidly connecting the first basinand the second basin.
 7. The device of claim 6, further comprising aplurality of LEDs connected to the microcontroller for signaling astatus of one or more operating parameters.
 8. The device of claim 7,wherein the device further comprises a replaceable power supply foroperating the motor.
 9. The device of claim 1, wherein the pressuresensor is fluidly connected to the vacuum port at a location between thepump and the vacuum port.
 10. The device of claim 1, wherein thepressure sensor is fluidly connected to the vacuum port at a locationbetween the at least one MEA and the oxygen port.
 11. An apparatus fortreating a wound comprising: a wound care device of claim 1; a dressingfor administering treatment to a wound, the dressing comprising anoxygen delivery manifold fluidly connected to the oxygen port, a gaseousmixture and exudates removal manifold fluidly connected to the vacuumport, and a wicking layer proximate the oxygen delivery manifold and thegaseous mixture and exudates removal manifold.
 12. A method of treatinga wound comprising: providing a wound care device of claim 1;positioning a dressing over a wound for administering topical continuousoxygen therapy and negative pressure wound therapy; connecting thedressing to the wound care device; activating operation of the woundcare device; supplying oxygen generated by the wound care device to thedressing; and applying a vacuum produced by the wound care device to thedressing.
 13. The method of claim 12, wherein activating operation ofthe wound care device initiates a seven-day treatment cycle thatcomprises topical continuous oxygen therapy and negative pressure woundtherapy.
 14. The method of claim 12, wherein activating operation of thewound care device initiates a seven-day treatment cycle that comprisestopical continuous oxygen therapy and intermittent negative pressurewound therapy.
 15. The device of claim 1, further comprising an oxygenconsuming device fluidly connected to the oxygen port, the oxygenconsuming device comprising: a second MEA comprising: a third electrodefluidly connected to the first basin, a fourth electrode spaced from thethird electrode, a second ion conducting membrane positioned between thethird electrode and the fourth electrode, a third conductive wireconnected to the third electrode, and a fourth conductive wire connectedto the fourth electrode, such that the application of a constant voltageacross the third conductive wire and the fourth conductive wireelectrochemically consumes oxygen from the first basin at the thirdelectrode.
 16. The device of claim 15, said operational modes furthercomprising a third operational mode in which the second MEA consumesoxygen from the oxygen port.
 17. The device of claim 16, wherein themicrocontroller regulates simultaneous operation of the firstoperational mode and the second operational mode.
 18. The device ofclaim 16, wherein the microcontroller regulates operation of the thirdoperational mode after regulating operation of the first operationalmode.
 19. The device of claim 16, wherein the second MEA in the thirdoperational mode consumes oxygen from the oxygen port at a rate greaterthan the oxygen generating rate in the first operational mode.
 20. Thedevice of claim 19, wherein the second MEA in the third operational modeconsumes oxygen from the oxygen port at a rate ranging from 5 to 50times greater than the oxygen generating rate in the first operationalmode.
 21. The device of claim 19, wherein consumption of oxygen by thesecond MEA in the third operational mode results in a vacuum applied bythe second MEA to the oxygen port.
 22. The device of claim 21, whereinthe vacuum applied by the second MEA to the oxygen port ranges from 1mmHg to 50 mmHg.
 23. The device of claim 16, wherein the microcontrollerregulates simultaneous operation of the first operational mode and thethird operational mode.